Kornimate/medical-research-clean huggingface dataset:
virtual reality glasses for the enhancement of acute brachytherapy tolerance for endometrial cancer patients.

Conditions: Endometrial Cancer

Summary: this randomized phase iii multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during vcb in patients treated for endometrial cancer, in terms of pain and anxiety.

endometrial cancer is one of the most common gynaecological cancers among women in the developed countries. after a curative surgical treatment, many relapses occur in the vaginal cuff. the portec-2 trial has demonstrated a similar reduction in local relapses of intermediate- to high-risk endometrial cancer with vaginal cuff brachytherapy (vcb) than with external beam radiotherapy (ebrt). however, vcb induced less late toxicities. vcb is therefore indicated after surgery for intermediate- to high-risk endometrial cancer. vcb is also recommended after radiation therapy, for patients with stage ii or iii type 1 endometrial cancers according to the international federation of gynaecology and obstetrics classification (figo), and for all patients with histological type 2 endometrial cancers. if the late tolerance of vcb is correct, the acute tolerance remains limited, and is mainly characterized by local pain and anxiety) virtual reality appears to be a promising tool to enhance treatment cancer tolerance, offering a safe and entertaining environment. by the way, the use of virtual reality could limit physical and psychical discomfort induced by vcb. this randomized phase iii multicenter trial aims to assess the impact of virtual reality helmets (visual and audio) during vcb in patients treated for endometrial cancer, in terms of pain (primary endpoint), and in terms of anxiety (secondary endpoint). randomization will define which patient will wear a virtual reality helmet. stratification will be performed according to the following criteria: vaginal molded applicator versus cylinder, two applications versus four; \ 70 years.

Eligibility criteria:
inclusion criteria: * patients over 18 years old. * patients with endometrial cancer, with histological type i and ii, regardless of the degree of differentiation. * patients with stage i, ii or iii endometrial cancer according to the figo classification. * patients treated with high-dose-rate vaginal cuff brachytherapy, with curative intent. * patients affiliated or entitled to a social security scheme. * patients who received information about the study and co-signed with the investigator the consent to participate at the study. exclusion criteria: * patients with stage iv endometrial cancer according to figo classification. * patients presenting recurrence of endometrial cancer. * pregnant or nursing women. * patients under protection of justice or unable to give consent.

Keywords: endometrial cancer brachytherapy virtual reality pain anxiety
effectiveness of self-myofascial stretching on carpal tunnel syndrome

Conditions: Patients With Stage I and II Carpal Tunnel Syndrome

Summary: background and aim: carpal tunnel syndrome (cts) also known as median mononeuropathy occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. the main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage i and ii cts. methodology: thirty-six subjects with stage i and ii cts who fulfilled the inclusion criteria were randomly assigned to experimental group and control group with 18 patients in each group. experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy while the control group received conventional physical therapy alone. the duration of the treatment was 6 weeks. the outcome measures used were boston carpal tunnel questionnaire and visual analogue scale.


Eligibility criteria:
inclusion criteria: * patients diagnosed with carpal tunnel syndrome. * age range between 30 - 60 years * both genders. * patients with stage i and ii (mild) carpal tunnel syndrome, confirmed by nerve conduction study (emg diagnosed by a medical professional) * unilateral and bilateral dominant hand. * patients who are able to read and understand english. exclusion criteria: participants with: * presence of polyneuropathy * consistent use of adaptive equipment, such as wheelchair or cane. * patients presenting with shoulder pathologies * patients with other neurological or musculoskeletal conditions as cervical radiculopathy, history of wrist and hand fractures, upper extremity joint dislocations, brachial plexus injuries, cubital tunnel syndrome, rheumatoid arthritis, de quervain's tenosynovitis, or cut injuries of hand. * patients who have underwent recent carpal tunnel release (within 1 year)
evaluate the effects of dapagliflozin in patients with type 2 diabetes

Conditions: Type-2 Diabetes; Oral Antidiabetics

Summary: this study will make it possible to better understand the mechanisms responsible for the increase in bad cholesterol levels observed in patients with type 2 diabetes treated with dapagliflozin, an antidiabetic treatment made by astrazeneca. the information will: * reveal what is not working properly * make it possible to choose the most appropriate treatments against cholesterol to compensate for this impaired functioning this biomedical research will take place at the university hospitals of dijon and nantes. * 28 patients will take part: 20 patients will be given dapagliflozin and 8 patients will be given the placebo. * the study treatment will be randomised: patients will be given either dapagliflozin or the placebo. the treatment duration is 6 months. * moreover, during the inclusion visit and at the end of the study (6 months after the start of treatment), a kinetics study, to follow the production and elimination of cholesterol, will be conducted. this will involve administering amino acids that have been specifically synthesised for this purpose. * participation in the study will last 6 months and include 4 protocol visits.


Eligibility criteria:
inclusion criteria: * persons who have provided written consent * type 2 diabetes treated with oad (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or dppiv inhibitors) * stable treatment for 3 months * hba1c between 7.5% and 10% * age between 30 and 65 years * bmi between 25 and 35 kg/m² * triglycerides \< 300 mg/dl * half of the patients being treated with statins * egfr \> 75 ml/min/1.73 m² at inclusion exclusion criteria: * persons without national health insurance cover * patients treated with insulin or a glp-1 agonist * patients under guardianship * patients treated with lipid-lowering drugs (except statins for 50% of patients) * kidney failure * liver failure or abnormal liver function asat or alat \>3 x upper limit of normal * total bilirubin \>2mg/dl * intestinal disease * serological evidence of an active liver infection (surface antigen of hepatitis b, hepatitis c antibodies, hepatitis b igm antibodies) * pregnancy, breastfeeding * hypersensitivity to the active substance or to excipients * patients with volume depletion, for example due to an acute disease (gastro-intestinal disease) * patients treated with loop diuretics or thiazides
clinical evaluation of the snap wound care system

Conditions: Acute and Chronic Wounds; Pressure Ulcers; Trauma Wounds; Diabetic Foot Ulcers; Venous Stasis Ulcers

Summary: the purpose of this study is to assess the efficacy of design improvements of the spiracur snap wound care system. this study prospectively evaluates the safety and efficacy of current and new design iterations of components of the fda-cleared spiracur snap wound care system in order to optimize safety, efficacy, and system performance.


Eligibility criteria:
inclusion criteria: * wound \< 10 cm in greatest diameter * patient \>18 years of age * willing and able to sign informed consent exclusion criteria: * patients with wound-related cellulitis * patients with thick eschar at wound base post debridement * patients with wounds located in an area not amenable to forming an air- tight seal * ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, raynaud's syndrome * patient has untreated osteomyelitis * patient is allergic to wound care products * patient wounds with exposed blood vessels not suitable for negative pressure therapy * pregnant or pregnancy-suspected patients * subject actively participating in other clinical trials that conflict with the current study

Keywords: negative pressure wound therapy npwt spiracur snap wound care system
clinical application comparison of two femtosecond laser systems

Conditions: Cataract

Summary: the goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (flacs) using two laser systems. participants will: undergo flacs using lensx or z8 femtosecond laser system visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests complete clinical measurements and dry eye questionnaires


Eligibility criteria:
inclusion criteria: 1. chinese han patients aged 40 years or older 2. clinical diagnosis of age-related cataracts; 3. underwent flacs with insertion of a posterior chamber iol for the first eye. exclusion criteria: 1. coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. patients with oct scans of poor quality were excluded; 2. preoperative flare of more than 15ph/ms11, ecd\<2000cells/mm2 or any other corneal pathologies; 3. coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye; 4. history of intraocular trauma, surgery, or retinal laser procedures; 5. usage of systemic or topical steroids or nsaids within one month prior to surgery; 6. patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation; 7. intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine; 8. ocular conditions contraindicating flacs including poorly dilated pupils (\<5.0mm), narrow palpebral fissure, small hyperopic eyes with steep cornea (difficult to achieve suction), severe conjunctival chalasis, nystagmus, or lack of cooperation; 9. potentially pregnant women; 10. known sensitivity to concomitant medications used during perioperative period, participation in other clinical trial during the time of visit, or poor cooperation in diagnostic tests or non-compliance at follow-up.
longitudinal and biological study of childhood disintegrative disorder

Conditions: Pervasive Child Development Disorders; Autism

Summary: objectives: i. compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays. ii. collect data on molecular genetics of proband and family members.

protocol outline: patients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: the autism diagnostic interview (adi); the autism diagnostic observation schedule (ados); assessment of cognitive functioning; expressive and receptive language; adaptive functioning; measures of burden and functional assessment; the aberrant behavior checklist; the connors rating scale - parent and teacher version; and autism behavior checklist an mri and eeg are performed, and blood samples are collected from patients and family members for molecular genetic studies.

Eligibility criteria:
* psychologically diagnosed (dsm-iv) as childhood disintegrative disorder * no known genetic or medical syndrome (down syndrome or cerebral palsy) * must speak english

Keywords: autism childhood disintegrative disorder neurologic and psychiatric disorders rare disease
the acute effect of spices on vascular health

Conditions: Oxidative Stress

Summary: the investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. metabolomic profiling will also be conducted. in random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. between each treatment there will be a washout period of at least 3 days. it is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.

a 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. metabolomic profiling will also be conducted. in random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. the following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme. endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.

Eligibility criteria:
inclusion criteria: * male aged 40-65 years * bmi 25-35kg/m2 * nonsmoking * waist circumference =/\> 94cm and at least one other cvd risk factor (elevated ldl-c (\> 130 mg/dl), crp (\> 1 mg/l), elevated triglycerides (≥ 150 mg/dl), reduced hdl-cholesterol (\< 40 mg/dl), elevated blood pressure (systolic bp ≥ 130 or diastolic bp ≥ 85 mm hg), elevated fasting glucose (≥ 100 mg/dl)) * low herb/spice consumers (consumption \<1/day) exclusion criteria: * chronic disease risk factors that are diagnostic of diabetes (fasting glucose \> 126 mg/dl) or hypertension (sbp \>160 mm hg or dbp \> 100 mm hg). * prescription of anti-hypertensive or glucose lowering drugs. * established cvd, stroke, diabetes, liver, kidney or autoimmune disease * use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals * weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study * vegetarianism

Keywords: glucose regulation lipids immune markers endothelium, vascular
study of etoposide, cisplatin, and radiotherapy versus paclitaxel, carboplatin and radiotherapy to treat non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard of care for patients with inoperable stage iii nsclc. the most common chemotherapeutic agents used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in conjunction with cisplatin or weekly paclitaxel and carboplatin. no randomized phase iii trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen over another. the clinical trial is to compare radiotherapy concurrently with pe (etoposide and cisplatin) and pc (paclitaxel and carbplatin) for local advanced nsclc (stage iiia/iiib). it is a randomized, multicenter, open labeled phase iii clinical trial. all patients receive conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. the chemotherapy regimens are pe (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 ) and pc (paclitaxel 45mg/m2 weekly over 1hour and carbplatin auc =2mg/ml/min over 30min weekly). the primary purpose is to evaluate objective response rate, complications, progression-free survival, overall survival. the second purpose is to evaluate quality of life and cost.


Eligibility criteria:
inclusion criteria: 1. inoperable stage iiia/iiib nsclc proved by pathology or cytology 2. age 18 to 75, ecog ≤ 2, lose weight \<10% during 6 months 3. no serious diseases of important organs 4. chest ct in recently 4 weeks 5. no other tumor disease except stage i cervical cancer or cutaneous basal cell carcinoma 6. sign consent 7. measurable lesion exclusion criteria: 1. pretreatment radiotherapy or chemotherapy 2. pregnant or lactation woman 3. serious diseases (include uncontrolled diabetes and infection) of important organs 4. psychopath 5. join in other clinical trial

Keywords: overall survival
microcurrent stimulation to treat macular degeneration

Conditions: Retinal Diseases; Stargardt's Disease; Retinitis Pigmentosa

Summary: microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

this is an observational study in which data will be collected from a group of patients with retinal diseases such as dry macular degeneration, retinitispigmentosa, and stargardt's disease, who have opted to receive microcurrent stimulation therapy as an alternative treatment for their retinal condition.

Eligibility criteria:
inclusion criteria: * ability to provide written consent and comply with follow up visits * age 40 years or older * etdrs best corrected visual acuity better than 5 letters * history of dry age relted macular degeneration; retinitis pigmentosa; stargardt's disease * no anti-vegf treatments for at least 3 months prior to study * no new antioxidant/vitamin supplementation for at least 3 months prior to study exclusion criteria: * history of non-compliance with regular medical visits * significant media opacities (exclude ns 4+) that may interfere with assessing visual acuity * presence of pigment epithelial tears or rips * known serious allergies to fluorescein dye * presence of retinal neovascularization * any treatment with an investigation agent in the past 30 days
high fiber rye foods for body weight and body fat reduction

Conditions: Obesity; Overweight

Summary: the overall aim of this study is to investigate whether a diet rich in rye fiber from wholegrain rye, compared to refined wheat, as part of a hypo-caloric diet leads to larger weight loss and lower body fat content after 12 weeks of intervention.


Eligibility criteria:
inclusion criteria: * men and women * age 30-70 y * bmi 27-35 kg/m2 * hemoglobin ≥117g/l for women and for men ≥134g/l * thyroid stimulating hormone (tsh) ≤4.30 miu/l * low density lipoprotein (ldl) cholesterol ≤5.30 mmol/l * triglycerides ≤2.60 mmol/l * signed informed consent exclusion criteria: * blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study * unable to satisfactorily complete the 3-day weighted food record between screening visits. * unable to lose ≥0.5 kg during the run-in period for men and women not having menstruation during the run-in period * increased body weight, despite reported adherence to dietary intake for women with menstruation during the run-in period. * using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.) * using e-cigarettes (regardless of nicotine content) * following any weight reduction program or having followed one during the last 6 months prior to visit 1. * diastolic blood pressure 105 mmhg or more at visit 1 * systolic blood pressure 160 mmhg or more at visit 1 * history of stomach or gastrointestinal conditions (inflammatory bowel disease, crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) * more than 10 hours physical activity per week * history of heart failure or heart attack within 1 year prior to screening * having type i diabetes * receiving pharmacological treatment for type ii diabetes (treatments based on life style interventions are acceptable, as long as they are compatible with the study protocol) * previous gastrointestinal surgery, with the exception of minor surgeries such removal of appendix or gall bladder at least 6 months prior to screening. * thyroid disorder * history of eating disorder * history of drug or alcohol abuse * stroke or transient ischemic attack (tia) within 1 year prior to screening * consumption of drugs aimed at weight management or drugs affecting body weight to a degree that is considered unsuitable for study participation by responsible physician. * pregnant, lactation or planning a pregnancy within the timeframe of the study. pregnancy must have ended at least 6 months prior to screening, and lactation must have ended at least 1 month prior to screening. * food allergies or intolerances preventing consumption of any products included in the study * strict vegetarian (participants must be able to consume the standardized meals used for appetite assessment) * unable to sufficiently understand written and spoken swedish to provide written consent and understand information and instructions from the study personal. * lack of suitability for participation in the study, for any reason, as judged by the medical doctor or pi.
hpv integration testing for cervical cancer screening

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia

Summary: the primary objective is to determine the sensitivity and specificity of the hpv integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (cin), using colposcopic inspection as the reference method. lesions will be confirmed as malignant or cin by colposcopic inspection and histopathologic examination.


Eligibility criteria:
inclusion criteria: women aged 30-65 years old attending the china population-based organised cervical screening program exclusion criteria: 1. not providing informed consent 2. previously confirmed cin, cervical cancer, or other malignancies 3. previous therapeutic procedure to cervix 4. pregnancy
the diep flap as a model of ischemia-reperfusion: an intervention study

Conditions: Ischemia-Reperfusion

Summary: the investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.


Eligibility criteria:
inclusion criteria: * patients undergoing breast reconstruction exclusion criteria: * diabetes mellitus * kidney or liver disease * use of immunosuppressants
safety and efficacy study of avastin in locally advanced metastatic or recurrent non-small lung cancer (nslc) participants

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: the purpose of this non-interventional study is the collection and documentation of data on safety and efficacy of intravenous (iv) bevacizumab (avastin) in addition to platinum-based chemotherapy for first-line treatment in participants with unresectable advanced, metastatic or recurrent non-small cell lung cancer (nsclc) other than predominantly squamous cell histology with focus on adenocarcinoma and elderly patients in daily routine.


Eligibility criteria:
inclusion criteria: * age greater than or equal to (\>=) 18 years * histologically confirmed predominantly non-squamous nsclc that is unresectably advanced, metastatic or recurrent (with or without adenocarcinoma) * no contraindications to avastin® according to the current summary of product characteristics (smpc) for avastin® * therapeutic decision for avastin® as first line treatment in combination with platinum-based chemotherapy was taken individually and independent of the non-interventional trial. exclusion criteria: n/a